The present invention relates to an anal dilator and occluder which may be utilized for dilating the anus for the purpose of medical treatment or serving as an occlusion device for patients suffering from fecal incontinence. More particularly, the present invention relates to a pneumatically operated apparatus adapted for such uses.
A significant number of patients have relative degrees of rectal stricture. A "rectal" stricture is a rather painful and annoying tightening of the lower end of the bowel, usually due to scar formation and usually at the base of the anus. Some rectal strictures are so severe that only a limited opening may be achieved. In such a case, it is difficult for the patient to excrete feces. A person with an anal stricture must essentially squeeze out his/her stool through a small aperture. This causes a significant degree of straining, and it is necessary for such people to frequently take stool softeners in order to keep out of trouble.
Often, the rectal or anal stricture may result from scarring following a hemorrhoidectomy.
Such rectal or anal stricture may be treated by considerable use of stool softeners, surgery or dilation of the anus. The surgical approach is usually regarded as a last resort since patients typically become incontinent following an anal sphincterotomy. This is so since the scar tissue (connective tissue) fibers are usually intertwined with the muscle fibers of the anal sphincter muscles and the anal sphincter muscles must be severed during the surgery. This results in a lax external sphincter and loss of control. It is believed that about fifty percent of the patients which become incontinent due to this surgery eventually regain continence after some period of time, but even in this fifty percent, the time period of incontinence is measured in months.
The more desirabled approach to anal or rectal strictures is that of dilation. The present invention provides a method and apparatus whereby such dilation may be done in a continuous, rather than a stepwise manner. Various types of fixed anal dialators are known in the prior art, such as those commercially available by the medical supply houses. However, none of these are anything like the pneumatic apparatus of the present invention. The present invention may be utilized to effectively treat anal strictures in a safe, efficient and more comfortable manner due to its pneumatic operation which provides a continuous range of dilation.
Another significant medical problem which may be treated by use of the anal dilator of the present invention is that of hemorrhoids. The use of anal dilation in the treatment of hemorrhoids has been recognized in the medical literature, for example see the Journal of Royal Society of Medicine, Volume 76, October 1983, pages 901 to 902. The pneumatic anal dilator of the present invention may be utilized in the treatment of hemorrhoids, which is a widespread medical problem. According to physiological concepts, when the pressure increases in the hemorrhoidal plexus of veins, the hemorrhoidal veins surrounding the anus tend to bulge. This sets up irritation and the irritaion causes the hemorrhoidal veins to bulge further. Although increased pressure in the portal vein due to cirrhosis may be a cause of hemorrhoids, due to the widespread occurrence of hemorrhoids, this is probably not the cause of hemorroids in the vast majority of people, but the hemorrhoids are caused in the majority by a cycle of irritation and swelling. Gentle counterpressure from a pneumatic anal dilator in accordance with the present invention may help significantly by interrupting the swelling and bulging parts of the cycle. The pneumatic anal dilator of the present invention would produce a counterpressure where the hemorrhoids would tend to prolapse.
Another significant and widespread problem which may be treated by the apparatus of the present invention is that of fecal incontinence. As the population ages, there tends to be an enlarging number of senile patients, and the severely senile patients are almost always incontinent of both urine and feces. It has been known in the prior art to control urinary incontinence by the use of an indwelling Foley catheter. However, the significant problem, and probably the more significant problem from both an aesthetic point of view and a nosocomial infection rate point of view, is that of the fecal incontinence. Fecally incontinent patients, both in nursing homes and hospitals, place a significant burden on the nursing staff with respect to the cleaning up of feces from fecally incontinent patients. In some nursing homes the number of fecally incontinent patients has been estimated to be between twenty-five to fifty percent of the patients. The burden from the point of view of nursing time, expense, and aesthetics is enormous when viewed in terms of the cleaning up of the feces which typically gets all over the patient, the pajamas, the bed clothes, the floor and sometimes even the wall. This is an aesthetics problem for both the patient and the nursing staff.
However, probably more importantly, fecal incontinence causes a serious problem with respect to the nosocomial infection rate. Even with the best of precautions, where twenty-five to fifty percent of the nursing home patients are fecally incontinent, the rooms have extensive coverage of coliform bacteria. It has been estimated that one of the most common causes of death in the geriatric population in nursing homes is that of infectious disease, often by gram-negative septicemia, greatly exceeding the rate at which patients succumb to vascular occlusive, embolic or neoplastic disease combined. The fecal incontinence problem also has a sever adverse effect in patients, particularly the senile, who may have sacral decubiti, with the feces contaminating these open sores.
The present invention is of significant value for anal dilation, treatment of hemorrhoids and fecal incontinence.